Rectal CancerPhase 2NCT06895577
Neoadjuvant Chemoradiotherapy Plus Sintilimab for MSS, Locally Advanced Rectal Cancer-
A Phase 2 study testing neoadjuvant SCRT followed by Sintilimab plus CAPOX in people with Rectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This research investigates the efficacy and safety of combining Sintilimab, a PD-1 inhibitor, with neoadjuvant chemoradiotherapy (NCRT) in patients with locally advanced microsatellite-stable (MSS) rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- neoadjuvant SCRT followed by Sintilimab plus CAPOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With my consent and signed informed consent, willing and able to comply with the planned visits, research treatment, laboratory tests, and other test procedures.
- Age 18-75. Patients with a pathologically or cytologically confirmed adenocarcinoma of the rectum, all other histological types excluded.
- The distance between the lower margin of the rectal tumor lesion and the anal margin <12 cm.
- The physical status score (ECOG) of the Eastern Cooperative Oncology Group was 0-1 (see Appendix 1).
- T3-4/N+ was evaluated by pelvic enhanced MRI. Had not received systemic anti-tumor therapy for colon cancer, including cytotoxic drugs, immune checkpoint inhibitor therapy, molecular targeted therapy, endocrine therapy, etc.
- Appropriate organ function based on the following laboratory test values obtained during the screening period: white blood cell count ≥3 × 10^9/L, neutrophil count ≥1.5 × 10^9/L, platelet count ≥75 × 10^9/L, serum total bilirubin ≤1.5 × upper limit of normal (UNL), AST (SGOT) or ALT (SGPT) ≤2.5 × UNL, serum creatinine ≤1.5 × UNL.
- Female subjects of reproductive age must undergo a negative serum pregnancy test within 3 days prior to the start of the study drug and be willing to use a medically approved highly effective contraceptive method (such as an IUD, contraceptive pill, or condom) during the study period and within 3 months after the last study drug administration; male subjects whose partners are women of reproductive age should be surgically sterilized or agree to use effective contraception during the study period and for 3 months after the last study dosing.
- Willing and able to comply with research procedures and visit plans.
Who cannot join
- Whole-body CT, MRI, or PET-CT confirms distant metastases (M1). Patients with complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery.
- The presence of other active malignancies in the past or at the same time (except malignancies that have received curative treatment and have been free of disease for more than 5 years or cancers in situ that can be cured by adequate treatment).
- Thrombotic or embolic events (e.g., cerebrovascular accident, including transient ischemic attack, pulmonary embolism, and deep vein thrombosis) occurred in the 12 months prior to study entry.
- Myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure in the 12 months prior to enrollment.
- Systemic antibiotic use ≥7 days within 4 weeks prior to enrollment, or unexplained fever >38.5°C during screening or prior to first dosing (fever due to tumor could be included).
- Had received major operations such as laparotomy, thoracotomy, laparoscopic resection of organs, or severe trauma within 2 months before enrollment (the surgical incision should be completely healed before enrollment in this clinical trial).
Show all 12Show fewer
- Known presence of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related disease.
- The presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acute pneumonia).
- Untreated active hepatitis (hepatitis B defined as HBV-DNA ≥500 IU/ml; hepatitis C defined as HCV-RNA above the lower detection limit of analytical methods) or co-infection with hepatitis B and hepatitis C.
- A known or suspected history of allergy to any of the relevant drugs used in the study.
- Pregnant or lactating women. Women of reproductive age who do not use effective non-hormonal contraception (or refuse to use it) or men who are likely to have children.
- The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the study or interfere with the study results, as well as patients deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangzhou, 510000
About this study
Official title: Neoadjuvant Chemoradiotherapy Plus Sintilimab for MSS, Locally Advanced Rectal Cancer: A Single-Center, Open-Label, Single-Arm, Phase 2 Trial
This research investigates the efficacy and safety of combining Sintilimab, a PD-1 inhibitor, with neoadjuvant chemoradiotherapy (NCRT) in patients with locally advanced microsatellite-stable (MSS) rectal cancer. Given the limitations of current treatment strategies in achieving optimal clinical outcomes, this prospective, single-center, phase II clinical trial aims to improve pathological complete response (pCR) rates and overall survival (OS). The primary endpoint is pCR, with secondary endpoints including disease-free survival (DFS) and the incidence of treatment-related adverse events. This study seeks to provide insights into a novel treatment paradigm for MSS locally advanced rectal cancer, potentially offering improved therapeutic options for this patient population.
Read the detailed description
Locally advanced rectal cancer (LARC) presents a complex treatment challenge, often requiring a multimodal approach to achieve optimal cure rates and improve survival. Currently, the combination of short-course radiotherapy (SCRT) and neoadjuvant chemotherapy has become a critical treatment strategy for LARC patients. Compared to conventional long-course radiotherapy (LCRT), SCRT is associated with a shorter treatment duration, typically lasting only five days, which facilitates rapid tumor shrinkage and minimizes surgical delays. This expedited treatment approach not only reduces the risk of postponing surgery but also improves the management of patients by minimizing fatigue and treatment-related side effects associated with longer regimens.
Despite the promising outcomes associated with SCRT and neoadjuvant chemotherapy, a significant proportion of patients still do not achieve satisfactory clinical responses to standard treatment regimens.
In recent years, the emergence of immune checkpoint inhibitors has revolutionized cancer treatment. In particular, PD-1 inhibitors such as Sintilimab have demonstrated significant antitumor activity across various solid tumors, notably in microsatellite instability-high (MSI-H) cancers. However, the potential benefits of these agents in microsatellite-stable (MSS) rectal cancer remain insufficiently explored.
This study aims to investigate the effects of combining Sintilimab with neoadjuvant chemotherapy and SCRT in a single-center, phase II trial for MSS locally advanced rectal cancer. By evaluating treatment responses and survival outcomes, we hope to provide a novel therapeutic option that enhances clinical efficacy for patients with LARC.
- Conditions
- Rectal Cancer
- Being tested
- neoadjuvant SCRT followed by Sintilimab plus CAPOX
- Keywords
- Rectal cancer, PD-1, neoadjuvant chemoradiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant SCRT followed by Sintilimab plus CAPOXDrug
SCRT (a total of 25 Gy in 5 days) followed by sintilimab (3mg/kg intravenous drip on day 1; every 3-week cycle for two cycles) combined with CAPOX (oxaliplatin 130 mg/m2 intravenous infusion over 2 h on day 1, capecitabine 1000 mg/m2 orally twice daily from day 1-14, in every 3-week cycle for two cycles) 1 week later.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant SCRT followed by Sintilimab plus CAPOX | Experimental | neoadjuvant SCRT followed by Sintilimab plus CAPOX Receives: Drug: neoadjuvant SCRT followed by Sintilimab plus CAPOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging
Measured: 1 month after the surgery
Secondary outcomes (5)
Margin-free (R0) resection rate
Measured: Immediately after the surgery
Tumor regression grade
Grading Standards TRG 0: Complete regression - No identifiable tumor cells remain. The tumor is entirely necrotic (dead).
TRG 1: Minimal regression - There are few viable tumor cells left. The tumor has significantly decreased in volume but is not completely gone.
TRG 2: Moderate regression - The tumor shows a mixed pattern. There are some necrotic areas, but viable tumor cells are still present.
TRG 3: Poor regression - The tumor remains largely intact, with only a small reduction in size. A significant number of viable tumor cells are still observable.
Measured: 1 month after surgery
Number of participants with surgical complications
Measured: 30 days after surgery
3-year event-free survival rate
Measured: 3-year event-free survival rate
Local recurrence
Defined as an intrapelvic recurrence following a primary rectal cancer resection, with or without distal metastasis.
Measured: 3 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start20 Jun 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Due to errors in the previously submitted modification, we request to withdraw it and will submit a corrected update shortly.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895577
- Sponsor's protocol ID
- GIHSYSU-37
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemoradiotherapy Plus Sintilimab for MSS, Locally Advanced Rectal Cancer: A Single-Center, Open-Label, Single-Arm, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT06895577
- Acronym / sponsor ID
- GIHSYSU-37
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, PD-1, neoadjuvant chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to errors in the previously submitted modification, we request to withdraw it and will submit a corrected update shortly.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research investigates the efficacy and safety of combining Sintilimab, a PD-1 inhibitor, with neoadjuvant chemoradiotherapy (NCRT) in patients with locally advanced microsatellite-stable (MSS) rectal cancer. Given the limitations of current treatment strategies in achieving optimal clinical outcomes, this prospective, single-center, phase II clinical trial aims to improve pathological complete response (pCR) rates and overall survival (OS). The primary endpoint is pCR, with secondary endpoints including disease-free survival (DFS) and the incidence of treatment-related adverse events. This study seeks to provide insights into a novel treatment paradigm for MSS locally advanced rectal cancer, potentially offering improved therapeutic options for this patient population.
Detailed description
Locally advanced rectal cancer (LARC) presents a complex treatment challenge, often requiring a multimodal approach to achieve optimal cure rates and improve survival. Currently, the combination of short-course radiotherapy (SCRT) and neoadjuvant chemotherapy has become a critical treatment strategy for LARC patients. Compared to conventional long-course radiotherapy (LCRT), SCRT is associated with a shorter treatment duration, typically lasting only five days, which facilitates rapid tumor shrinkage and minimizes surgical delays. This expedited treatment approach not only reduces the risk of postponing surgery but also improves the management of patients by minimizing fatigue and treatment-related side effects associated with longer regimens.
Despite the promising outcomes associated with SCRT and neoadjuvant chemotherapy, a significant proportion of patients still do not achieve satisfactory clinical responses to standard treatment regimens.
In recent years, the emergence of immune checkpoint inhibitors has revolutionized cancer treatment. In particular, PD-1 inhibitors such as Sintilimab have demonstrated significant antitumor activity across various solid tumors, notably in microsatellite instability-high (MSI-H) cancers. However, the potential benefits of these agents in microsatellite-stable (MSS) rectal cancer remain insufficiently explored.
This study aims to investigate the effects of combining Sintilimab with neoadjuvant chemotherapy and SCRT in a single-center, phase II trial for MSS locally advanced rectal cancer. By evaluating treatment responses and survival outcomes, we hope to provide a novel therapeutic option that enhances clinical efficacy for patients with LARC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant SCRT followed by Sintilimab plus CAPOX | Experimental | Drug: neoadjuvant SCRT followed by Sintilimab plus CAPOXneoadjuvant SCRT followed by Sintilimab plus CAPOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- With my consent and signed informed consent, willing and able to comply with the planned visits, research treatment, laboratory tests, and other test procedures.
- Age 18-75. Patients with a pathologically or cytologically confirmed adenocarcinoma of the rectum, all other histological types excluded.
- The distance between the lower margin of the rectal tumor lesion and the anal margin <12 cm.
- The physical status score (ECOG) of the Eastern Cooperative Oncology Group was 0-1 (see Appendix 1).
- T3-4/N+ was evaluated by pelvic enhanced MRI. Had not received systemic anti-tumor therapy for colon cancer, including cytotoxic drugs, immune checkpoint inhibitor therapy, molecular targeted therapy, endocrine therapy, etc.
Key exclusion criteria (12 listed)
- Whole-body CT, MRI, or PET-CT confirms distant metastases (M1). Patients with complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery.
- The presence of other active malignancies in the past or at the same time (except malignancies that have received curative treatment and have been free of disease for more than 5 years or cancers in situ that can be cured by adequate treatment).
- Thrombotic or embolic events (e.g., cerebrovascular accident, including transient ischemic attack, pulmonary embolism, and deep vein thrombosis) occurred in the 12 months prior to study entry.
- Myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure in the 12 months prior to enrollment.
- Systemic antibiotic use ≥7 days within 4 weeks prior to enrollment, or unexplained fever >38.5°C during screening or prior to first dosing (fever due to tumor could be included).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoadjuvant SCRT followed by Sintilimab plus CAPOXSCRT (a total of 25 Gy in 5 days) followed by sintilimab (3mg/kg intravenous drip on day 1; every 3-week cycle for two cycles) combined with CAPOX (oxaliplatin 130 mg/m2 intravenous infusion over 2 h on day 1, capecitabine 1000 mg/m2 orally twice daily from day 1-14, in every 3-week cycle for two cycles) 1 week later. | Drug | neoadjuvant SCRT followed by Sintilimab plus CAPOX |
Primary outcome
Pathological complete response
Time frame: 1 month after the surgery
Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging
5 secondary outcomes
Margin-free (R0) resection rate
Time frame: Immediately after the surgery
Tumor regression grade
Time frame: 1 month after surgery
Number of participants with surgical complications
Time frame: 30 days after surgery
3-year event-free survival rate
Time frame: 3-year event-free survival rate
Local recurrence
Time frame: 3 years after the surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing neoadjuvant SCRT followed by Sintilimab plus CAPOX in people with Rectal Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (time frame: 1 month after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.